A comparison of the efficacy of oral fumarate and methotrexate therapy in the treatment of severe psoriasis.

A comparison of the efficacy of oral fumarate and methotrexate therapy in the treatment of severe psoriasis: a prospective randomized controlled clinical trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21850

Enrollment

Registered

2006-08-01

Start date

2006-09-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis vulgaris

Interventions

Patients will be randomized to receive either fumarate or methotrexate therapy. The total study-duration will be 16 weeks with a follow-up for 4 weeks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients should be at least 18 years with a maximum age of 65 years. 2. Patients should suffer from chronic plaque-type psoriasis. 3. PASI >8.

Exclusion criteria

Exclusion criteria: 1. Patients with other forms of psoriasis like psoriasis guttata or pustulosa. 2. Patients who have received prior treatment with either fumarates or methotrexate. 3. Patients in need of co-medications that may influence psoriasis, the clinical response of either fumarates or methotrexate, or toxitcity of either fumarates or methotrexate. 4. Acute infections requiring antimicrobial therapy or associated with HIV infection. 5. Hepatitis B, C, HIV. 6. Pregnancy, breast-feeding, desire to have children within 3 months after the cessation of therapy, unacceptable or non-compliant contraception. 7. Body-weight under 50 kg. 8. Obesity ( Body mass Index 30-40). 9. Relevant cardiovascular, pulmonary, celebral, neurological, hematological, liver or renal impairments. 10. (Insulin-dependent) Diabetes mellitus. 11. Hypertension defined as diastolic pressure higher than 95 mmHg, or a systolic pressure higher than 160 mmHg. 12. High risk of liver function disturbances like genetic abnormalities, relevant abnormality in the liver by ultrasound. 13. Chronic constrictive heart failure. 14. History of arsenic medication, malignancy, carcinogenic therapy, immunosuppressive medication. 15. Anemia, leukopenia, thrombocytopenia, high serum creatinin, any blood transfusions. 16. Drug or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
PASI (psoriasis area severity index-)-score.	—

Secondary

Measure	Time frame
PGA (physician global assessment) Blood and urine samples will be collected for laboratory tests.	—

Contacts

Public ContactS. Fallah-Arani

Erasmus Medical Center Dermatology Department P.O. Box 2040

s.fallaharani@erasmusmc.nl+31 (0)10 4639222

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)